UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053103 |
|---|---|
| Receipt number | R000056952 |
| Scientific Title | Efficacy of fan therapy for dyspnea in intensive care unit patients after lung transplantation: controlled before-after study |
| Date of disclosure of the study information | 2023/12/14 |
| Last modified on | 2024/05/27 12:45:52 |
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Basic information
Public title
Efficacy of fan therapy for dyspnea in intensive care unit patients after lung transplantation: controlled before-after study
Acronym
Efficacy of fan therapy for dyspnea in intensive care unit patients after lung transplantation: controlled before-after study
Scientific Title
Efficacy of fan therapy for dyspnea in intensive care unit patients after lung transplantation: controlled before-after study
Scientific Title:Acronym
Efficacy of fan therapy for dyspnea in intensive care unit patients after lung transplantation: controlled before-after study
Region
| Japan |
Condition
Condition
Lung transplant recipient
Classification by specialty
| Chest surgery | Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy of using fan therapy after lung transplantation and the feasibility of future intervention studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Primary outcome is change in the severity of breathlessness score using a Numerical Rating Score(NRS) and the Japanese version of the Respiratory Distress Observation Scale (RDOS). NRS and RDOS assessment are completed before and after the intervention/ control.
Key secondary outcomes
Secondary outcome is respiratory rate, oxygen saturation of peripheral artery, blood pressure, numerical rating score of anxiety, face tempture and discomfort of fan.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Table fan directed to face, the airflow to the region innervated by 2nd and 3rd trigeminal nerve branches, for 5 minutes
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 18 years of age who received lung transplantation
Key exclusion criteria
(1) Patients who are unable to cooperate with the study
(2) Patients with diseases or treatment affecting the trigeminal nerve supply
(3) Patients who are not able to communicate in Japanese
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Tomoo |
| Middle name | |
| Last name | Sato |
Organization
Kobe City College of Nursing
Division name
Adult and Child Health Care Nursing Region
Zip code
651-2103
Address
3-4, Gakuen-Nishi-machi, Nishi-ku, Kobe City
TEL
078-794-8085
t-sato@kobe-ccn.ac.jp
Public contact
Name of contact person
| 1st name | Tomoo |
| Middle name | |
| Last name | Sato |
Organization
Kobe City College of Nursing
Division name
Adult and Child Health Care Nursing Region
Zip code
651-2103
Address
3-4, Gakuen-Nishi-machi, Nishi-ku, Kobe City
TEL
078-794-8085
Homepage URL
t-sato@kobe-ccn.ac.jp
Sponsor or person
Institute
Public University Corporation
Institute
Department
Personal name
Tomoo Sato
Funding Source
Organization
Kobe City College of Nursing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City of college of Nursing
Address
3-4, Gakuen-Nishi-machi, Nishi-ku, Kobe City
Tel
078-794-8085
t-sato@kobe-ccn.a.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/251182-fan-therapy-for-dyspnea-in-lung-transplant-recipients-in-the-
Number of participants that the trial has enrolled
8
Results
The mean (SD) numerical rating scale (NRS) for dyspnea before and after fan therapy was 5.6 (2.3) and 4.4 (1.5), respectively (p = 0.08). The mean (SD) respiratory distress observation scale (RDOS) before and after fan therapy was 4.8 (2.0) and 3.8 (1.7), respectively (p = 0.03).
Results date posted
| 2024 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 10 | Day |
Baseline Characteristics
Lung transplant recipients (age >18 years) who experienced dyspnea during their ICU stay.
Participant flow
Adverse events
No serious adverse events were observed, and no significant alterations were observed in the respiratory rate, oxygen saturation levels, pulse rate, or blood pressure.
Outcome measures
The primary outcome was the change in dyspnea before and after fan therapy, which was measured using the Dyspnea NRS for subjective evaluation and RDOS for objective evaluation.
Secondary outcomes included respiratory rate, SpO2, blood pressure, anxiety NRS score, and facial skin temperature.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056952
